HOW ROBUST ARE AUSTRALIA’S REGULATIONS?

The medical technology industry in Australia has endured its fair share of targeted attacks by special interest groups over the years. So, a recent coordinated effort by a U.S.-based group to use its global influence to question the robustness of the Australian regulatory system and the wider MedTech industry has made many sit up and take notice.

When questions about safety are raised it’s understandable that people, by their nature, might assume the worst is true. But is it? PulseLine wanted to go to the source and find out just how robust Australia’s system is when it comes to medical devices.

In Australia MedTech companies are represented by a national association called the Medical Technology Association of Australia (MTAA). The aim of MTAA is to ensure the benefits of modern, innovative and reliable MedTech are delivered effectively to provide Australians with better health outcomes and an improved quality of life.

MTAA CEO, Ian Burgess, believes millions of Australians’ lives have been transformed by having a medical device thanks to the Australian MedTech industry making safety as its highest priority.

“MedTech has improved the lives of millions of people right across Australia, thanks primarily to the efforts made by MedTech companies, government and medical practitioners placing such a high priority on the safety of medical devices being used in Australia,” Mr Burgess said.

“When it comes to ensuring we have a robust and thorough process for approving medical devices for the Australian market, MTAA are the first to advocate for a consistent and evidence-based approach to regulations.”

In Australia, the regulatory process is governed by a risk-based system of classification that determines the level of scrutiny a medical device will be subjected to before it is included in the Australian Register of Therapeutic Goods (ARTG). A medical device must be on the ARTG before it can be lawfully supplied in or imported into Australia.

The regulator responsible for overseeing this process in Australia is the Therapeutic Goods Administration (TGA) which assesses medical devices in line with a device’s intended purpose and risk-based classification. This includes:

A pre-market assessment – called a conformity assessment;

Market authorisation – so the device can be included on the ARTG; and

Post-market monitoring – which ensures the device continues to comply with all of the regulatory, safety and performance requirements and standards.

We all know how fast technology changes in today’s world. So, when it comes to regulations keeping up with that change, we wanted to know what the MedTech industry and government were doing to keep pace.

It turns out that in 2016 the Australian Government announced a series of reforms and projects to improve the regulatory process. These include moving towards global harmonisation, achieving appropriate classification for classes of medical devices based on risk, and working with sponsors and manufacturers to manage emerging issues in the post-market space.

Department of Health Deputy Secretary, Adjunct Professor John Skerritt, highlighted to PulseLine that TGA uses a number of sources of information to monitor the ongoing safety of medical devices included in the ARTG.

When it comes to monitoring the safety of post-market devices, the TGA receives “signals from multiple sources including notifications and information from other regulators, compulsory reporting from manufacturers and sponsors, competitors and whistle-blowers, media and government,” Professor Skerritt said.

“Reporting of adverse events and issues associated with the use of medical devices plays a vital role in identifying emerging issues that may require regulatory action or legislation change.”

Medical devices in Australia are subjected to a robust regulatory approval and legal framework, which requires device companies to report adverse events to the TGA.

So, when you consider the millions of medical devices Australians have successfully implanted, or interact with each year, it’s clear the regulatory process has a strong track record for ensuring safety for all Australians.